AML WHO tumor classification
Item
1. acute myeloid leukemia diagnosed by who criteria with one of the following:
boolean
C0023467 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Refractory Disease | Status post Induction Chemotherapy Quantity
Item
primary refractory disease following no more than 2 cycles of induction chemotherapy
boolean
C1514815 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C3179010 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
First Relapse | Absence Prior Chemotherapy Unsuccessful
Item
first relapse with no prior unsuccessful salvage chemotherapy
boolean
C4054953 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Age
Item
2. age between 18 and 70 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status ≤ 3
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
4. adequate organ function defined as:
boolean
C0678852 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance ≥ 50 ml/min
boolean
C2711451 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Due to Leukemia | Exception Leukemic infiltration hepatic | Exception Obstruction of biliary tree Due to Leukemia
Item
ast, alt, total bilirubin ≤ 2 x uln except when in the opinion of treating physician is due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0023418 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1142074 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0400979 (UMLS CUI [6,2])
C0678226 (UMLS CUI [6,3])
C0023418 (UMLS CUI [6,4])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
left ventricular ejection fraction of ≥ 40% by muga scan or echocardiogram
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Infertility | Sexual sterilization | Contraceptive methods Willing
Item
5. are surgically or biologically sterile or willing to practice acceptable birth control, as follows:
boolean
C0021359 (UMLS CUI [1])
C0038288 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0600109 (UMLS CUI [3,2])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Contraceptives, Oral | Intrauterine Devices | Transdermal contraception | Contraceptive implant | Injectable contraception | Sexual Abstinence
Item
females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. acceptable methods of birth control include oral contraceptive, intrauterine device (iud), transdermal/implanted or injected contraceptives and abstinence.
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C0009905 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C1168146 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C1262153 (UMLS CUI [9])
C0036899 (UMLS CUI [10])
Gender Sexual Abstinence | Gender Contraceptive methods Willing
Item
males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Informed Consent
Item
6. able to provide signed informed consent prior to registration on study
boolean
C0021430 (UMLS CUI [1])
Acute Promyelocytic Leukemia
Item
1. acute promyelocytic leukemia (aml with t(15;17)(q22;q11) and variants)
boolean
C0023487 (UMLS CUI [1])
Blast count Peripheral blood
Item
2. peripheral blood blast count ≥ 20 x 103 /mm3
boolean
C0523113 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Central nervous system leukemia
Item
3. active cns involvement with leukemia
boolean
C1332884 (UMLS CUI [1])
MEC regimen
Item
4. previous treatment with mec or other regimen containing both mitoxantrone and etoposide
boolean
C0286540 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
5. pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs | Cytotoxic Chemotherapy | Exception hydroxyurea
Item
6. received any other investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within the preceding 2 weeks
boolean
C0013230 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0020402 (UMLS CUI [3,2])
filgrastim | sargramostim | pegfilgrastim
Item
7. received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study
boolean
C0210630 (UMLS CUI [1])
C0216231 (UMLS CUI [2])
C1136535 (UMLS CUI [3])
Comorbidity Severe Limiting Protocol Compliance
Item
8. severe concurrent illness that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])